The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0666-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk

MWT Materials, Inc. is recalling six Accusorb MRI Breast Shields because they may overheat when not used correctly, posing a risk of patient injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential patient injury from overheating) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

MWT Materials, Inc. is recalling six units of the Accusorb MRI Breast Shield (Part Number: MRI-07). These products are radio frequency shielding blankets and body-part covers designed for use in the MRI environment.

The recall was initiated because the products may overheat when not used correctly, which could lead to patient injury. The affected units were distributed nationwide in the United States, specifically in the states of New York and Massachusetts.

Healthcare facilities and consumers who possess these specific MRI breast shields should stop using them immediately and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Manufacturer
MWT Materials, Inc.
Category
Medical Device — MRI Accessories
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by MWT Materials, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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